MULTIPLE FUNCTION VASCULAR DEVICE
A multi-purpose vascular device defines a lumen allowing fluid communication there through and has a coil with a side of the coil winds having solid physical connections between the coil winds to prevent the connected coil wind side from expanding following the application of force by an actuating member which causes the connected coil winds to have a predetermined configuration in an unstressed state. The application of longitudinal force causes the unconnected coil winds to expand, resulting in the vascular device assuming a different configuration.
The present invention relates to apparatus and methods for performing surgical procedures that access hollow conduits of mammalian anatomy. More particularly, the invention discloses a multi-function device for navigating tortuous vascular pathways, reaching and then crossing total occlusions in blood vessels.
BACKGROUNDIntracorporal medical devices have been developed and used to navigate and access the tortuous vascular and other hollow conduits of a mammalian body. Some of these devices include guidewires, catheters, intravenous guidewires, stylets, intravenous catheters and related devices like endoscopes and colonoscopes that have a predetermined degree of flexibility and may have straight or pre-formed, shaped ends to guide the device through the anatomical conduit. Of the devices that are employed to reach vascular blockages, each has certain advantages and disadvantages. Many fall short of desired performance before reaching a vascular blockage because of a device prolapse at a vascular bifurcation, an inability to enter a bifurcation or be directed to the site of therapy. Others may reach an occlusion but then require a different device to be introduced before crossing the stenosis. The medical industry has striven to reach a balance between the flexibility required to negotiate around tortuous pathways and the rigidity necessary to stabilize a catheter's advancement. Many products such as intravenous interventional guidewires provide directability, flexibility or stiffness but fail to do all or a combination at the same time. These products typically have pre-formed flexible distal ends that provide minimal directability but not true directability, flexibility and stiffness combined, which would be the most useful advantage. Additionally, most physicians must use a series of different diameter guidewires to perform one procedure, creating a procedure that costs additional time, money and risks patient safety from vascular injury.
Accessing occlusions having relatively sharp angles and passage constrictions using conventional guidewires having pre-formed “J” shapes or angled distal ends requires rotating the guidewire while simultaneously moving it proximally and distally. This action can cause damage to the fragile endothelial cell layer lining blood vessels. Additionally, conventional guidewires can lose their ability to be rotated when the flexible distal ends enter vessels of reduced diameter. Rotation of the guidewire following inserting the distal end into a vessel having a reduced diameter produces high frictional forces between the walls of the small vessels and the guidewire. A desirable device would therefore require reduced rotation and increased ability to advance in a forward or distal direction through tortuous anatomies.
Another undesirable characteristic of conventional guidewires is the inability to support a catheter at the flexible, tapered, distal end. When a catheter is advanced toward a vascular location in and close to a bifurcation, the catheter tends to proceed in a straight line rather than following the guidewire, defined as prolapse. Further, the natural pulsation of the vascular system of a living animal can cause a conventional guidewire to move into or out of the body during the procedure, thereby losing its distal location.
An additional disadvantage of a general use catheter is that it must be inserted into the body over a guidewire. Therefore, both a catheter and a guidewire must be used to reach a targeted site within the body. A single device that functions as an independent guidewire or both a catheter and a guidewire would save procedural time, reduce patient recovery time and cause less vascular damage to the patient.
Still another disadvantage related to current practices resides in the catheter itself. Conventional catheters typically have totally open distal ends. Manufacturers have made efforts to design catheters with soft distal ends to minimize the extent of vascular damage when the open end engages the interior wall of blood vessels. This scraping of the endothelial layer results in a triggering of the auto immune system, causing clots to form at the damage site. Also, the distal end of the catheter may become clogged with material removed from the interior wall of the blood vessels. It is apparent that this bolus of material will be expelled from the distal catheter end when another device is inserted through the catheter. An all-in-one device having a soft, closed distal end that opens to allow other devices to be deployed from the distal end and then re-closing when the devices are withdrawn, would resolve this problem.
Once the occlusion is reached, the objective is to cross the blockage with the guidewire or remove the guidewire and insert yet another device to cut through the occlusion. This is inherently disadvantageous in that additional time is required and a greater risk of vascular damage or perforation of the vessel wall is presented. Conventional devices used to cross the blockage are generally stiffer than conventional guidewires and when inside the catheter and reaching a bifurcation can cause the more flexible catheter to move away from the target site and follow the guide into the opposite branch of the bifurcation.
Physicians generally have four objectives when using such vascular devices: (1) To reach the occlusion; (2) To reach the occlusion without causing vascular damage; (3) To cross the occlusion once it is reached; and (4) To reach the occlusion and cross it in as little time as possible. A device able to accomplish all four objectives would be extremely advantageous. It is not uncommon for a physician to place a catheter somewhere in a vessel and exchange the first guidewire with one or more secondary guidewires having progressively stiffer distal ends to prevent prolapse of the devices placed over the guidewire(s). Yet another advantage would be having a guidewire stiff enough to be pushed and yet be directed into branched vessels with minimal torquing. Still another advantage would be a multi-function device able to carry a second device that could bore its way through an occlusion.
Vascular occlusions defined as Chronic Total Occulsions are blockages that can occur anywhere in a patient's vascular system, including coronary, carotid, renal, iliac, femoral, cerebral, popliteal and other peripheral arteries.
U.S. Pat. No. 4,676,249 to Arenas discloses a guidewire having a moving internal member to provide stiffness when required, but does not disclose a directable distal end or the ability to cross occlusions. Another U.S. Pat. No. 5,542,434, discloses a longitudinally movable core wire made of a memory metal alloy that stiffens when subjected to thermal energy. This allows the wire to become stiff and yet torquable when desired, but fails when a catheter needs to be slid over the device. Both devices are deficient when they reach an occlusion with heavily calcified plaque in that they do not have the ability to bore through the occlusion.
Using a conventional guidewire to reach the occlusion requires a catheter to be pushed over the guidewire, the final guidewire removed and then another device to be pushed through the catheter and used to cross the blockage. Such devices are generally known as percutaneous transluminal thrombectomy or artherectomy devices. These devices have various means to cross the occlusion and are singular devices lacking the ability to solely navigate the vasculature. As an example, one such device is disclosed in U.S. Pat. No. 6,945,951 and describes a thrombectomy catheter using high velocity saline through jets that erode away the blockage and cross an occlusion.
For all these and other reasons there is a clear need for a single device that can vary its distal end, is relatively stiff, has the ability to cross an occlusion and/or a feature that can drill or bore its way through an occlusion.
SUMMARYIn one aspect, the invention is directed to a vascular device including a shaft defining a longitudinal dimension, a lumen allowing fluid communication through the shaft extending along the longitudinal dimension and a proximal section and a distal section. The distal section further defines a weak side and a strong side and an actuating member is attached to the distal section, with the actuating member being capable of transmitting longitudinal force to the distal section. When longitudinal force is applied to the actuating member, the weak side of the distal section increases in size while the strong side maintains substantially the same size, resulting in the distal section deflecting.
In another aspect, the invention is directed to a vascular device including a shaft defining a lateral dimension, a longitudinal dimension, a proximal section, a distal section having greater flexibility than the proximal section and a lumen allowing access through the shaft extending along the longitudinal dimension. The shaft at least partly defines a coil, and the coil further defines a distal end. An actuating member is attached to the coil, and is capable of transferring longitudinal force to the coil. A side of the coil winds is physically connected, defining a connected side, which maintains the coil winds on the connected side in a constant configuration preventing differential spacing resulting from the application of longitudinal force and causing the connected coil winds to have a predetermined configuration in an unstressed state. When longitudinal force is applied to the actuating member, an unconnected side of the coil winds expands, resulting in the vascular device assuming a stressed configuration having a different shape than the vascular device in the unstressed configuration.
In a further aspect the invention is directed to a vascular device, including a shaft defining a lateral dimension, a longitudinal dimension, a proximal section, a distal section having greater flexibility than the proximal section and a lumen allowing access through the shaft extending along the longitudinal dimension. The shaft at least partly defines a coil, with the coil further defining a distal end. A flexible cutting shaft extends through the lumen and defines a proximal end and a distal end, with a cutting burr attached to the distal end of the cutting shaft. An actuating member is attached to the coil and is capable of transferring longitudinal force to the coil. A side of the coil winds is physically connected and defines a connected side, which maintains the coil winds on the connected side in a constant configuration preventing differential spacing resulting from the application of longitudinal force and causing the connected coil winds to have a predetermined configuration in an unstressed state. When longitudinal force is applied to the actuating member an unconnected side of the coil winds expands, resulting in the vascular device assuming a stressed configuration having a different shape than the vascular device in the unstressed configuration.
50 Catheter
400 Vascular Device
402 Hollow Shaft
402a Proximal Termination of Hollow Shaft
402b Distal Termination of Hollow Shaft
404 Actuating Member
406 Coil
406a Open Wound Coil Section
406b Solid Coil Section
407 Distal Section
408 Weld
410 Distal Lumen Opening
412 Proximal End of Solid Coil Section
414 First Lumen
416 Second Lumen
418 Ribbon
420 Cutting Head
422 First Handle
423 Third Handle
424 Cutting Shaft
424a Proximal End of Cutting Shaft
424b Distal End of Cutting Shaft
425 Second Handle
426 Flattened Section of Coil
428 Solder
430 Non-Expandable Side
432 Expandable Side
500 Vascular Device
502 Hollow Shaft
504 Actuating Member
505 Sheath
506 Distal End (of Vascular Device)
508 Slit
510 Coil
510a Open Wound Coil Section
510b Solid Coil Section
512 Weld
514 First Lumen
516 Second Lumen
517 Distal Section
518 Ribbon
520 Cutting Head
524 Cutting Shaft
524a Proximal End of Cutting Shaft
524b Distal End of Cutting Shaft
526 Flattened Section of Coil
528 Solder
530 Non-Expandable Side
532 Expandable Side
534 First Handle
536 Second Handle
600 Vascular Device
602 Coating
604 Actuating Member
606 First Lumen
608 Coil
610 Second Lumen
612 Ribbon
614 Open Coil Section
615 Flattened Section of Coil
616 Distal Closed Coil Section
617 Distal Section (of Vascular Device)
618 Actuating Member Attachment
620 Distal First Lumen Opening
622 Non-Expandable Side
624 Expandable Side
626 Handle
628 Proximal Closed Coil Section
718 Cutting Shaft
720 Cutting Head
722 Angle in Cutting Shaft
1000 Vascular Vessel
1002 Vascular Obstruction
1002a Attached Obstruction
1002b Obstruction Debris
1400 Vascular Device
1410 Central Space
1412 Distal Section
1412a Loose Wound Section
1412b Tight Wound Section
1414 Coil
1415 Proximal Coil Section
1416 Flattened Section of Coil
1418 Ribbon
1420 Hollow Member
1422 Lumen
1424 Solder
1426 Coating
1428 Distal End of Vascular Device
1429 Proximal End of Coil
1430 Actuating Member
1432 Actuating Member Attachment
1434 Distal End of Coil
1436 Distal Lumen Opening
1438 Non-Expandable Side
1440 Expandable Side
1442 Handle
Definitions“Anatomical Conduit” refers to a naturally occurring vessel or duct within a patient's body.
“Distal” means further from the point controlled by the operator (e.g., physician or technician) of a device.
“Distal Force” means force applied in a distal direction or toward a distal end of the device.
“ePTFE” means expanded polytetrafluoroethylene.
“FEP” means fluorinated ethylene-propylene.
“Handle” means a device used to grip certain components of the invention for the purpose of causing longitudinal movement of additional components.
“Longitudinal Force” means either distal force or proximal force.
“Prolapse” refers to an adverse event occurring when a medical device does not follow the desired path at a vascular bifurcation but instead where a relatively stiff device forces a relatively less stiff device straight through the vessel, pulling the less stiff device out of the side branch of the bifurcation.
“Proximal” means closer to the point controlled by the operator (e.g., physician or technician) of a device.
“Proximal Force” means force applied in a proximal direction or toward a proximal end of the device.
“PTFE” means polytetrafluoroethylene.
ConstructionThe following detailed description is to be read with reference to the drawings in which similar components in different drawings have the same nomenclature. The drawings, which are not necessarily to scale, show illustrative embodiments and are not intended to limit the scope of the invention.
It should be noted that combinations of materials and components described within this specification may be interchangeable and anyone skilled in the art will understand that a combination of materials or exchange of other materials to accomplish the work of the invention will not depart from the spirit of the invention. It is further understood that the invention is not limited to vascular use and can also be applied to use through an endoscope, gastroenterological procedures, laparoscope, artherectomy procedures, urological procedures or neurological procedures.
For the purpose of describing the actuation of the embodiments of the invention 600, 1400 as described below, a handle 626, 1442 is used. The function of the handle 626, 1442 is to contact the coated coil 608, 1414, move the actuating member 604, 1430 and provide greater control to the operator. Using the handle 626, 1442 allows the application of a longitudinal force (distal or proximal) from a proximal end (unnumbered) of the device 600, 1400 to the attached actuating member 604 and proximal force to the actuating member 1430, which causes a sliding motion. As described in detail below, the application of longitudinal force causes a distal section 617, 1412 of the vascular device 600, 1400 to deflect. In the cases of the embodiments of the invention 400, 500 a first handle 422, 534, contacts the hollow shaft 402, 502 and is attached to the actuating member 404, 504 allowing longitudinal force to be applied to the distal section 407, 517, causing it to deflect. A second handle 425, 536 is attached to a cutting head 420, 520 which distally extends from a distal lumen opening 410 or a sheath 505 and manually rotated in procedures requiring plaque removal.
When distal force is applied to the actuating member 604 by the operator, as shown in
As shown in
When distal force is applied to the actuating member 404 by the operator, as shown in
As shown in
When distal force is applied to the actuating member 504 by the operator, as shown in
The outer diameter of the vascular device 400, 500, 600, 1400 is manufactured to dimensions that are industry standards for certain medical procedures and can range from between approximately 0.006 inch to 0.121 inch which allows passage through a ten French catheter at 0.131 inch outer diameter, as an example. The length of the vascular device 400, 500, 600, 1400 is similarly manufactured to conform to industry standards and may range between approximately 10 centimeters to 300 centimeters as required by the particular medical procedure.
UseUsing the vascular device 400, 500, 600, 1400 of the present invention first requires removal from sterile packaging. Standard surgical techniques are employed to incise the proper blood vessel or bodily duct using an introducer having one or more sealed ports. The introducer can range in diameter from 4 to 24 French depending on the vessel or bodily duct size and location. Most procedures performed for Percutaneous Transluminal Coronary Angioplasty (PTCA) use a 6 to 10 French device passing through the introducer. A 6 to 10 French catheter having an open and blunt distal end can cause vascular damage passing through the vessels. Therefore one embodiment of the invention described herein discloses a rounded, bulleted distal end. The introducer is placed into the vessel lumen and is followed by insertion of a guidewire, catheter or other medical device that can pass transluminally through the vessel to the site of therapy. A rounded distal end will facilitate this task with less vascular damage.
The vascular device 400, 500, 600, 1400 is then inserted into the introducer and carefully navigated through the patient's vasculature until the treatment site is reached.
At that point, either the vascular device 400, 500, 600, 1400 is used to complete the procedure or another device is passed over or through the vascular device 400, 500, 600, 1400. At the completion of the procedure the vascular device 400, 500, 600, 1400 is disposed of.
In the embodiments 400, 500 as described above, the invention may be employed as a combination guidewire and thrombectomy or atherectomy device to remove calcified plaque or venous thrombosis. When these embodiments of the vascular device 400, 500 are used the physician places the distal end 410, 506 near the obstruction and a radio opaque contrast material may be injected into the artery through a lumen in the device, after which the physician advances a second handle 425, 536 at the proximal end (unnumbered) to deploy the cutting head 420, 520 at the distal end 410, 506 and slowly advance the device while manually rotating the second handle 425, 536. Aspiration may be used to remove the debris detached and displaced by the cutting head 420, 520. Upon completion of the procedure, the vascular device 400, 500 is removed and disposed of. These embodiments allow the physician to navigate a single device to the diseased area and complete the procedure in the shortest time with the least amount of vascular damage.
While the invention as described above can be used as a combination guidewire/thrombectomy/atherectomy device, it can also be used a catheter. Most transfemoral coronary catheterization employ between a 4 and 10 French catheter. Small arteries will utilize around a 4 French catheter while larger arteries could utilize up to a 10 French catheter. Cited by the Journal of the American Medical Association, upward of three million cardiac catheterizations are performed annually in the United States. A device to reduce procedural time vascular damage would be an economic advantage to the industry. The vascular device 400, 500, 600, 1400 may be applied to a variety of medical devices capable of being introduced into the vasculature or other anatomy of a patient. For example, the vascular device 400, 500, 600, 1400 could be applied to singular guidewires, guidewire/catheter combination (e.g., balloon angioplasty, stent deliver, drug delivery, fluid delivery or fluid removal), as a conduit for atherectomy devices and NUS catheters, laparoscopic and endoscopic devices, spinal or cranial navigation devices, neurostimulation and cardiac resynchronization leads, embolic protection devices, therapeutic devices and other medical devices. When used for drug delivery the invention finds utility by being able to remove fluid causing the surrounding area to lose excess fluid. A drug can then be injected and the affected area will more readily absorb the drug by the osmotic difference in pressure. This allows the drug to remain at the site rather than be carried away by the movement of interstitial fluids.
The vascular device 600, 1400 finds further utility in the implantation of neurostimulation or resynchronization leads which are typically 30 to 60 cm long. Currently these leads must include a large lumen for the insertion of a preformed stylet to steer the lead to the target site. As the industry continues to reduce the diameter of these leads to 4.1 French or less by removing the stylet lumen, a device is needed to steer the leads to the target site and allow the physician to rotate the lead (not shown) at the proximal end to implant the lead. The vascular device 600, 1400 accomplishes this by providing an open lumen from the proximal end (unnumbered) to the distal end 620, 1436 while allowing the distal end 620, 1436 to be manipulatively deflected by the physician and the proximal end of the lead manually rotated. Following implantation of the lead the invention is removed and disposed of.
Claims
1. A vascular device, comprising:
- a flexible shaft having a length, a lumen extending in a linear manner the length of the shaft and defining first and second open ends allowing unrestricted fluid communication through the lumen, a proximal section and a distal section;
- the distal section comprising a coil comprising a plurality of coil winds defining an outer periphery and a central space, the distal section having a weak side and a strong side; and
- an actuating member attached to the outer periphery of the distal section, the actuating member capable of transmitting longitudinal force to the distal section;
- wherein applying longitudinal force to the actuating member causes the weak side of the distal section to increase in length while the strong side maintains substantially the same length, resulting in the distal section deflecting.
2. The vascular device of claim 1 wherein the actuating member is attached to a distal end of the distal section.
3. The vascular device of claim 1 wherein in a non-stressed configuration the vascular device has a straight configuration and applying distal force to the actuating member causes the distal section to deflect.
4. The vascular device of claim 1 wherein in a non-stressed configuration the vascular device has a straight configuration and applying proximal force to the actuating member causes the distal section to deflect.
5. The vascular device of claim 1 wherein the actuating member comprises a ribbon attached to the outer periphery of the coil.
6. The vascular device of claim 5 wherein the ribbon is attached to the outer periphery of the coil at at least two of the plurality of coil winds at an external flat section on the at least two of the plurality of coil winds.
7. The vascular device of claim 6 wherein the ribbon is attached to the coil at each of the plurality of coil winds at an external flat section on each of the plurality of coil winds.
8. The vascular device of claim 1 further comprising a flexible cutting shaft extending through the lumen, the cutting shaft having a distal end with a cutting burr attached to the distal end of the cutting shaft.
9. The vascular device of claim 8 wherein the cutting shaft is made of superelastic nitinol.
10. The vascular device of claim 8 wherein at least the distal end of the cutting shaft includes a sheath.
11. A vascular device, comprising:
- a flexible shaft having a lateral dimension, a length, a proximal section, a distal section having greater flexibility than the proximal section and a lumen extending in a linear manner the length of the shaft and defining first and second open ends allowing unrestricted access between first and second open ends of the lumen;
- a helical coil comprising a plurality of coil winds at least partly defining the shaft, the coil having an outer periphery and a distal end;
- an actuating member attached to the outer periphery of the coil, the actuating member capable of transferring longitudinal force to the coil; and
- at least two of the coil winds being physically connected by the actuating member, defining a connected side, to maintain the coil winds on the connected side in a constant configuration preventing differential spacing resulting from the application of longitudinal force and causing the connected coil winds to have a predetermined configuration in an unstressed state;
- wherein the application of longitudinal force to the actuating member causes an unconnected side of the coil winds to expand, resulting in the vascular device assuming a stressed configuration having a different shape than the vascular device in the unstressed configuration.
12. The vascular device of claim 11 wherein the device in the unstressed state has a straight configuration and applying longitudinal force to the actuating member causes the distal section to deflect away from the longitudinal dimension.
13. The vascular device of claim 11 wherein the device in the unstressed state has a non-straight configuration and applying longitudinal force to the actuating member causes the distal section to deflect toward the longitudinal dimension.
14. The vascular device of claim 11 wherein the at least two connected coil winds being physically connected by a metallic ribbon having a rectangular cross section attached to the coil.
15. The vascular device of claim 14 wherein the ribbon is connected to an external flat section formed into a surface of the outer periphery of the at least two connected coil winds.
16. A vascular device comprising:
- a distal shaft section having an expandable side and a non-expandable side, the distal shaft section comprising a coil defining a first central space and comprising a plurality of coil winds, and an external flat section on the plurality of coil winds;
- a proximal shaft section defining a second central space coaxial with the first central space;
- a lumen defined by the first central space and the second central space, the lumen having first and second open ends allowing unrestricted fluid communication through the lumen;
- a ribbon attached to the external flat section of each of the plurality of coil winds; and
- an actuating member attached to the distal shaft section and capable of transferring longitudinal force to the coil.
17. The vascular device of claim 16 further comprising a flexible cutting shaft extending through the lumen, the cutting shaft having a distal end with a cutting burr attached to the distal end of the cutting shaft.
18. The vascular device of claim 17 wherein the cutting shaft is made of superelastic nitinol.
19. The vascular device of claim 17 wherein at least the distal end of the cutting shaft includes a sheath.
Type: Application
Filed: Apr 1, 2016
Publication Date: Sep 22, 2016
Patent Grant number: 10172638
Inventors: Robert A. Palme (Lindstrom, MN), Gregory L. Townsend (Motley, MN)
Application Number: 15/089,103